Clinical trial · Interventional
Sorafenib and Interferon Alfa in Treating Patients With Locally Advanced or Metastatic Kidney Cancer
A Phase 2 Study Of BAY 43-9006 In Combination With Interferon Alfa-2b In Metastatic Renal Cell Cancer
NCT00098618CI-TRIAL-00011173terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth or by blocking blood flow to the tumor. Interferon alfa may interfere with the growth of tumor cells and slow the growth of kidney cancer. Sorafenib may help interferon alfa kill more tumor cells by making tumor cells more sensitive to the drug. Giving sorafenib together with interferon alfa may kill more tumor cells. This phase II trial is studying how well giving sorafenib with interferon alfa works in treating patients with locally advanced or metastatic kidney cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Papillary Renal Cell Carcinoma | Papillary Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage III Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| recombinant interferon alfa | Biological | — | UNRESOLVED |
| sorafenib tosylate | Drug | Sorafenib Tosylate | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (sorafenib tosylate and recombinant interferon alfa)
- description
- Patients receive oral sorafenib twice daily and interferon alfa subcutaneously three times a week for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity
- interventionNames
- Drug: sorafenib tosylate
- Biological: recombinant interferon alfa
- Other: laboratory biomarker analysis
Primary outcomes (5)
- measure
- Overall response rate (CR+PR) using RECIST criteria
- timeFrame
- Up to 5 years
- description
- CR+PR rate will be calculated with exact 90% confidence intervals.
- measure
- Grade 3+ toxicities assessed using NCI CTCAE version 3.0
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed renal cell carcinoma * Locally advanced or metastatic disease * All histologic subtypes allowed * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No known brain metastases or leptomeningeal disease * Performance status - ECOG 0-2 * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * No bleeding diathesis * Bilirubin normal * AST and ALT ≤ 2.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 times ULN * Creatinine clearance ≥ 60 mL/min * No uncontrolled hypertension * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of sensitivity to E. coli-derived products * No history of severe depression * No active infection requiring antibiotics * No seizure disorder requiring antiepileptic medication * No medical condition likely to require systemic corticosteroids * No autoimmune disorder that could result in life-threatening complications * No other uncontrolled illness * No psychiatric illness or social situation that would preclude study compliance * No more than 1 prior biologic response modifier regimen * At least 4 weeks since prior biologic response modifiers * No prior interferon alfa * No prior chemotherapy * At least 4 weeks since prior radiotherapy to non-index lesions * Prior radiotherapy to index lesion allowed provided irradiated lesion progressed ≥ 20% in diameter * At least 2 weeks since prior major surgery * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent therapeutic anticoagulation therapy * Concurrent prophylactic anticoagulation, such as low-dose warfarin, for venous or arterial access device allowed provided PT, PTT, and INR are normal * No other concurrent investigational agents * No other concurrent anticancer therapy
References
Publications (0)
Data not yet available
No reference posted for this study.